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IS DIGITAL MEDICINE A STANDARDS NIGHTMARE

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					                       Standard Making: A Critical Research Frontier for Information Systems
                                         MISQ Special Issue Workshop




            IS DIGITAL MEDICINE A STANDARDS NIGHTMARE?

     Thomas Lucy-Bouler, Ph.D.                                  Dan Morgenstern, M.D.
    Auburn University Montgomery                            Auburn University Montgomery
      Information Systems Dept.                               Information Systems Dept.
            (334) 244-3462                                  dmorgensternmd@yahoo.com
          Fax (334) 244-3792
       tlucybo1@mail.aum.edu

                                                 ABSTRACT
       As technology has increased, one industry that has been slow in implementing
       technology is the healthcare industry. Doctors, with handheld devices, going room to
       room with real time information on each patient is not a reality in most hospitals today.
       Implementation has been slowed by multiple standards for healthcare data, and the
       HIPAA act that has brought up security issues for patient data. Also, research is being
       done in two non-convergent fields. This paper describes the standards and the problems
       with developing healthcare information systems.

Keywords: Healthcare MIS, Health Level 7, Medical Information Bus, Digital Imaging
Communications in Medicine, Data Communication Standards, Digital Medicine.

                                        INTRODUCTION
Healthcare management information systems are some of the most complex systems
developed today. Healthcare providers, from individual doctors to hospital HMOs, want more
technology integration into the system providing real time data analysis and the possibility of
enhancing medical knowledge. Sharing that knowledge can lead to what many describe as
“digital medicine” where stored clinical data can generate medical knowledge which can be
widely distributed, incorporated into decision support systems, and lead to more effective
medical practices (Shaffer, Kigin, Kaput, Gazelle 2002).

In order to achieve digital medicine, the collection of medical information to be retrieved and
analyzed is necessary in real time. The equipment that monitors patients, the information
recorded by nurses and even the images created in x-rays and MRIs must be stored in the
system so that doctors can review all the data relevant to a patient to determine the proper
treatment. Three standards specific to the healthcare field exist that healthcare information
system developers must incorporate into any project so that data can be collected and stored.
Any healthcare system developed incorporates these standards, which are still being developed
and improved, plus standard networking protocols, and government induced standards for
personal information security due to the recent Health Insurance Portability and Accountability
Act (HIPAA). Medical Informatics is a new discipline which is directly influencing the
development of information system in healthcare. Traditional MIS must recognize the problems
in development of healthcare information systems, and the joint research possibilities with
Medical Informatics researchers in solving many of the yet to be resolved issues of data
collection and analysis in helping make digital medicine a reality.

This paper will examine three aspects related to the problems in developing healthcare
information systems. The first aspect will be the security and privacy issues associated with
digital medicine. The second aspect will be the standards for data collection that have been
developed, specifically the Health Level Seven (HL7) data model standard, the Medical



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Information Bus (MIB) standard for portable medical devices, and the Digital Imaging and
Communications in Medicine (DICOM) standard for medical images. Finally, the last aspect will
be the need for more joint research into the system architecture and need for a complete
architecture of a medical information system that can lead to digital medicine.

    PRIVACY AND OTHER RESTRICTIONS ON HEALTHCARE INFORMATION SYSTEMS
The communication standards developed for healthcare equipment and information, specifically
the clinical and administrative data generated in hospitals are still developing and, now with the
HIPPA requirements, can be the major success or failure factor of any installed healthcare
information system. HIPAA has created an urgent need for common standards in the data
exchange within hospitals and to external insurance suppliers. HIPAA requirements for security
requires all involved with administering patient information to implement basic safeguards to
protect electronically stored health information from unauthorized access, alteration, deletion,
and transmission. With wireless technology being implemented in hospitals, the security of
information on those wireless networks is necessary for HIPAA compliance. In order to make
digital medicine a reality, access to patient information from other healthcare workers is
necessary without revealing private information.

To create decision support systems and medical knowledge bases will require careful
consideration on the uses of patient data which are restricted under HIPAA. Anyone who has
visited a doctor recently has signed waiver forms on the privacy of their medical records.
Individual privacy concerns could hamper development or implementation of a real time
knowledge base.

  HEALTHCARE INFORMATION SYSTEM DATA MODEL AND COLLECTION STANDARDS
In health care, specifically hospitals, the different electronic systems that have to connect to a
real time information system that can provide doctors with timely information on patients poses
an almost overwhelming communications problem. Each piece of equipment that monitors a
patient should be capable of electronic data interchange within the hospital’s network.
Standards have been developed for the equipment that allows electronic data interchange.
These standards are capable of providing a software developer the necessary tools that could
allow for a fully integrated health care system that not only dealt with the patient records, but
with the real time information on the patient’s status while in the hospital. Doctors could use this
information to provide better medical care.

Three standards are available for the system developer. The Health Level Seven (HL7), the
Medical Information Bus (MIB or IEEE P1073), and Digital Imaging and Communications in
Medicine (DICOM) all have had an enormous impact on health care information systems and
patient care. Each of these standards impacts the data gathering and exchange of information
within a health care information system. Wireless communications also presents a new security
threat for the network systems, and also HIPAA compliance. So far, a new security standard for
healthcare MIS has not been developed.

These three standards encompass data standards (HL7), communication standards (MIB) and
digital imaging standards (DICOM). Software vendors must rely on all three of the standards to
get a complete medical system useful for hospitals. These real-time systems are available, but
with old equipment, hospitals can’t switch directly to the new systems. That is why most
healthcare software developers work with the equipment manufacturers to develop drivers for
the older equipment. With each custom ‘driver’, the software vendor must expand the system
and the potential of incompatibility increases. Each standard is described below focusing on the
problems of each in terms of security, incompatibility and implementation.


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Although these standards are widely known in the Medical Informatics field, they are not
commonplace terminology in the MIS field. Networking protocols, such as TCP/IP and Ethernet
are used in healthcare systems, but are only the transport protocols, not the implementation
(MIB) or the data standards (HL7 and DICOM). Since healthcare information systems must
integrate with other systems, such as insurance companies and government agencies, the
standards for data models and data access become more important to the success of a
healthcare information system. Since most MIS researchers do not understand these standards,
a short description of each standard is given.

                                      Health Level 7 (HL7)
The HL7 committee was founded in 1987 in an attempt to develop standards for the storage and
exchange of clinical, financial and administrative information generated by such hospital areas
as laboratory, pharmacy, admissions, etc. It was designated as an accredited standards
developer by ANSI (American National Standards Institute) in June of 1994. HL7 has grown
from its modest beginnings to become “the” standard for vendors and most prominent hospitals
the world over. It essentially is a protocol for electronic data exchange, defining transmission
transactions for patient registration, insurance, billing, orders and results of laboratory and
physiologic tests, imaging studies, observations, nurses’ notes, diet and pharmacy orders and
inventory/supply orders. In 2002, the National Committee on Vital and Health Statistics
(NCVHS) recommended HL7 as the primary Patient Medical Records Information (PMRI)
message format standard. That same committee adopted DICOM, NCPDP SCRIPT (from the
National Council for Prescription Drug Programs) and IEEE 1073 (MIB) be recognized as
standards for specific PMRI market segments.

HL7 is very flexible, being an “open system,” which has led to some confusion and vendor
“sales pitch stretch” as far as the issues of connectivity and “HL7 compliance” are concerned. In
relation to the seven layer OSI model, HL7 is a seventh layer, application standard. It defines
the data to be exchanged, sets timing of such exchanges and manages error messages
between applications. It assumes compatible protocols for layers 1-6 and herein lies one of the
difficulties of “HL7 compatibility” insofar as different I.T. routes may be taken in those layers to
reach the application layer. Different systems from different vendors for aspects of the
information system for a hospital could be incompatible in the other layers, especially the
network layer.

The flexibility of the HL7 standard-which gives rise to this compatibility issue- is important
because the level of care, demographic patient base, payer mix, content of physician versus
respiratory therapy orders, etc. differs from institution to institution. Data fields differ widely from
hospital to outpatient surgical center to multi-speciality clinic office. In its latest version (HL7
3.0), the issue of flexibility has received considerable attention and indeed is being scaled back
as the problems of compatibility abound. (“The reduced optionality will greatly help HL7 to
approach plug and play specificity. The slogan for Version 3 is, "optionality is a four-letter
word."”) (Health Level Seven Organization, 2001) Thus, an ongoing attempt to streamline the
collection and retrieval of “static data,” which HL7 represents, promises even more in the way of
“plug and play” which the medical as well as general public has come to expect. Indeed, HLV3
as it is known represents a complete “rethinking” of the delivery of clinical information, as it is
built around the concept of a single object model, the HL7 Reference Information Model (RIM.)
The HL7 Board of Directors has proposed this as the solution to :
         “The most intractable barrier to the application of information technology in
         healthcare has been the lack of standards for exchanging fine-grained, highly



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         heterogeneous, structured clinical data among information systems. The strength
         of Version 3 messaging is the exchange of fine-grained data without bilateral
         negotiations." (Health Level Seven Organization, 2001)
It is felt that the adoption of HL7 V3 with its RIM which allows for the use of 96 hierarchical
message descriptors (HMDs) that delineate specific message types which can be “implemented
as a unique, but compatible XML schema” will advance the cause of a single, integrated suite of
standards for health care informatics around the world. So far, the only evidence that this may
come true is the adoption of HL7 by the NCVHS as the message standard.

                                Medical Information Bus (MIB)
             MIB’s scope: “To provide for open systems communications in
             health care applications, primarily between bedside medical devices and
             patient care information systems, optimized for the acute care setting.”
             MIB’s purpose: “To allow hospitals and other health care providers
             to interface medical instrumentation to host computer systems in a manner
             that is compatible with the patient care environment.” (IEEE MIB Website, 2002)

The critical care areas of a hospital represent a formidable challenge from an information
systems standpoint (and from a health care standpoint too, I might add.) This is an area where
the requirements for data generation, interpretation, status changes, alarms, safety and
reliability, are far beyond those required of typical and “standard issue” computer hardware and
software. The number of “device riders” on the “bus” can easily go from one to 7-8-10 within a
matter of moments as a patient’s status changes rapidly. It is not uncommon for patient
monitors to suddenly and quickly increase their displays from simple EKG and temperature to 5-
6-7 lines of waveform data, accompanied by a profusion of IMED (intravenous) pumps, a
ventilator and cardiac support pumps within minutes. This is the environment where “plug and
play” is not a desirable, comfortable, lazy man’s feature but a matter of life and death. And
indeed this was recognized very early on, in 1984, when the IEEE (Institute of Electrical and
Electronic Engineers) founded the committee charged with writing the “Standard for Medical
Device Communications.” This committee, which produced the family of standards known as
IEEE P1073 (MIB) has continued working to this day and needless to say has rewritten the
standards several times in a continuing effort to reach a true plug and play environment where
the manufacturer, model number, vintage (within reason) of a needed piece of equipment is of
no consequence in the overall care/information picture except in so far as it performs its
clinically designated task.

MIB is a model that focuses on object orientation- that is entities defined as objects by the MIB
model, be they pumps, monitors, ventilators, etc. They may also include patients, doctors,
nurses, therapists- in short all the “Virtual Medical Objects” in play at and around the bedside,
as defined by MIB, using the Medical Device Data Language (MDDL). Since the objects,
information, access to the information and usage /display of the information all are addressed by
MIB, it is- in contradistinction to HL7- a full seven layer protocol stack in the OSI model. The
lower layers cover the equivalent of what in an office would be covered by Ethernet and TCP/IP-
that is the physical connections, topology and transmission protocols. Considerable effort was
expended in the area of connections, grounding and safety, given the sometimes less than ideal
environment in which these devices must function. Star topology- specified by MIB- can also be
viewed as a safety device in so far as it prevents a single cable failure from bringing down the
entire local device network (i.e. attached to one patient). MIB also specifies a once per second
device polling to ensure prompt failure recognition.




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The upper layers of the MIB OSI protocol stack define content, format, structure and syntax of
the message in question. This area is of crucial importance for- unlike HL7 which is designed
for PC and workstation type equipment, where significant computing power is available and
where upper layers are loaded into the machine via the applications- MIB deals with micro
controller and micro processor based equipment with little processing power and little if any
programmability. In addition, these devices are mobile, and must be connected and
disconnected several times daily by non IT trained clinicians who neither know, nor care to
learn, the finer points of network programming.

The upper layer protocol work has progressed slower than the lower. The IEEE has purposely
attempted to standardize device classes, such as infusion pumps (the first to be standardized -
IEEE 1073.1.3.1) in order to define parameters, attributes and services in a logical fashion. In
addition, the Andover Working Group, a consortium of IT and healthcare companies under the
direction of HP, has also continued work in this area and indeed has been one of the champions
of standards based networks in this area. Finally, it cannot be ignored that MIB devices are by
definition FDA regulated, which adds additional engineering, clinical and clerical “hoops to jump
through” and which impacts the speed of advance of this work.

                  Digital Imaging and Communications in Medicine (DICOM)
Soon after the advent of CT (computerized tomography) scanners in the late 1980's, it became
apparent that a method of storage and transmission of radiographic and other images more
efficient than the traditional X-ray file room was needed. The American College of Radiology
and the National Electrical Manufacturers Association formed a joint committee in 1983 to
develop interfaces and standards relating to imaging equipment and other medical electronic
equipment. The first version of DICOM was published in 1985 and has undergone several
revisions. (DICOM Standard Website at National Emergency Management Agency, 2001)

In its present form, DICOM 3.0 is a full 7 layer OSI protocol stack. This is indeed necessary
given the bewilderingly different pieces of equipment from an impressive array of vendors that
make up even a relatively unsophisticated radiological department. DICOM 3.0 addresses
interoperability and such questions as: commands, information objects (CT scan, barium enema
etc.) and their attributes, data element tagging, naming and semantics (interpretation),encoding
rules for data stream construction, message exchange, all of which allow applications to
establish sessions, transfer messages (data) and terminate sessions. DICOM 3 allows support
of numerous OSI protocol stacks, to include Ethernet, FDDI, ISDN, X.25, TCP/IP and other LAN
and WAN technologies. However, DICOM physical layer protocols specify a 50 pin cable to
accommodate the large data transfer requirements inherent in medical imaging.

As in the previous discussion on MIB, the environment of DICOM devices can be less than
ideal. More importantly, the crucial aspect of virtual every byte of information in the
reconstruction of images cannot be overestimated. The presence of errors in, or the failure of
transmission of but a few bytes out of millions can render an image unreadable as understood in
the clinical sense of the word. Indeed, recognizing that digital radiological images vary from
0.064 Mbytes per exam image(nuclear medicine scan) to 32 Mb per exam image(computerized
radiography) and bearing in mind that transmission rates via a DS-0 would vary from 59 sec to
76 minutes gives the reader some idea of the magnitude of data accumulation, transmission
and the extraordinarily low tolerance for error in this area of medical information technology.

Work continues on the DICOM standard, in particular on interface with HL7, crucial to enable
demographic and other data needed for radiological examination to flow smoothly from the
“static” to the “imaging” portions of hospital care. Once again, however, the term “DICOM


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compliant” needs to be taken with a grain of salt when emanating from a vendor, for the sheer
complexity and size of DICOM standards is such that no products currently implement it totally.
Thus, careful consideration of the “non compliant” areas is in order and adequate planning for
interfacing at those points is mandatory.

          RESEARCH POSSIBILITIES IN HEALTHCARE INFORMATION SYSTEMS
Even though these standard organizations are starting to work toward integration of the
standards, there are still no interface standards between them. With many hospitals integrating
wireless technology, each standard organization must come up with security aspects of the
standards that can ensure encryption of the data that meets or exceeds the necessary security
requirements for securing the data over wireless networks. Compatibility issues of interfaces for
portable equipment within the hospital setting is forcing software vendors and manufacturers to
write special ‘drivers’ for all the possible equipment from all the different equipment
manufacturers. Even though the Medical Information Bus (MIB) standard is for the portable
equipment, older equipment used in hospitals don’t have the MIB interface yet are still used in
most hospitals today. Recent research suggesting that medical errors can be reduced with more
technology integration also points out the problems with dealing with complex standards,
government regulation and policies, and even physicians that are not technically savvy (Chung,
Choi and Moon 2003).

Joint research efforts between MIS and Medical Informatics can lead to solutions for building
healthcare information systems which encompass the complexity of multiple standards, provide
real time/life saving access to information, and still satisfy the business processes of a hospital.
Add to the complexity the legacy systems most hospitals have and the complexity of installation
without data loss or service interruption multiplies.

Medical informatics has defined the two technology areas that need to converge as information
processing methodology (IPM) and information and communication technology (ICT).
Convergence and clearly defining the technology areas involved in successful design of
healthcare information systems are research areas. Potential research areas have been defined
for informatics in the areas of the electronic patient records (which relates to the HL7 standard),
system architectures for medical information systems, and medical knowledge bases (Haux,
2002).

As vendors integrate the standards into the systems they sell to hospitals, the complexity of the
task to fully automate and digitize all the information that any one patient can generate at one
time, and all the data gathering equipment to be tied to the system, along with any image data
that is needed in real time by primary and surgical care providers is also compounded by the
legacy systems that most hospitals have with patient data that they can’t afford not to tie into a
new system.

Other areas for future research are defined by research that suggests managed care has limited
the technology development and adoption in the healthcare area. A review finds limited
literature on technology adoption affected by managed care (Baker, 2002). Integration of
wireless technology, for instance, increases complexity of systems by requiring compliance to
HIPAA, and requiring data collection and access security problems. Some researchers already
recognize problems with wireless technology that they say will hinder the availability in hospitals
due to interference with existing medical devices, and no immediate communication of urgent
messages (Helsop, Howard, Fernando, Rothfield and Wallace 2003). Technological influence
on patient treatments and treatment trajectories can lead to digital medicine. Social medicine
researchers are already researching the socio-cultural influence of technology in health care


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(Mechanic, 2002). Training in technology is necessary for healthcare workers, especially
physicians, to use the technologies most efficiently and effectively. Defining the role of the
physician in digital medicine, and therefore the training necessary for the physician has also
been an area of research (Howell, 1999).

Most research in this area is from the medical side, while the amount of research in healthcare
information systems in MIS is minimal in comparison. The value add from joint research to
establish system architecture standards, knowledge base development research techniques,
communication standards, system integration with legacy systems, and the potential of
developing digital medicine can lead to great advances and rapid solutions to many of the
problems outlined in this paper.

                                        REFERENCES
Baker L., “Managed Care, Medical Technology, and the Well-Being of Society.” Topics in
       Magnetic Resonance Imaging 2002 April; 13(2):107-113.
Chung K, Choi YB, Moon S. “Toward Efficient Medication Error Reduction: Error-Reducing
       Information Management Systems.” Journal of Medical System 2003 Dec;27(6):553-560.
Haux R., “Health Care in the Information Society: What Should be the Role of Medical
       Informatics?” Methods of Information in Medicine 2002; 41(1): 31-35.
Heslop L, Howard A, Fernando J, Rothfield A, Wallace L., “Wireless Communications in Acute
       Health-Care.” Journal of Telemedicine and Telecare 2003;9(4):187-93.
Howell JD. “The Physician's Role in a World of Technology.” Academic Medicine 1999
       Mar;74(3):244-247.
Mechanic, D., “Socio-Cultural Implications of Changing Organizational Technologies in the
       Provision of Care.” Social Science in Medicine 2002 Feb;54(3):459-467.
Shaffer DW, Kigin CM, Kaput JJ, Gazelle GS., “What is digital medicine?”, Studies in Health
       Technology and Informatics 2002;80:195-204.
Health Level Seven Organization Website, http://www.hl7.org/ Press Release Ann Arbor
       Michigan, August 16 2001
IEEE MIB Group Archives, http://grouper.ieee.org/groups/mib/archives/1073gr.htm
National       Emergency       Medical       Agency,      DICOM        Strategy   Standard,
       http://medical.nema.org/dicom/geninfo/dicomstrategyv105/StrategyJuly0601.htm

Author’s Biographies
Dr. Thomas Lucy-Bouler is an Associate Professor at Auburn University Montgomery. His
research interests have included small business information systems, neural networks, and
recently healthcare information systems.

Dr. Dan Morgenstern, M.D., is a recently retired cardiovascular thoracic surgeon. His interest
in healthcare informastion systems comes from personal experience and recent firsthand
experience at an implementation of a new information system where he worked. He teaches
courses at Auburn University Montgomery in MIS.




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